MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305902
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle sftygld 23x1 rb needle went through the shield.The following information was provided by the initial reporter: material #305902.Lot #5157464.Verbatim: rcc received a complaint via phone.Pir attached.Productcomplaint - customer called to report the bd 305902 lot 5157464, had a bent needle and this was discovered while opening the package, which resulted in a needle stick of a staff.Sample is available.Doe 10/06.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.A bent needle was reported upon opening the package, resulting in a needle stick injury.To support the investigation, two samples were submitted for evaluation by the quality team.One sample was received without a packaging blister, while the other was in a sealed blister package.A visual inspection was conducted on both samples.The sample in the sealed blister package exhibited no defects or imperfections.The sample without the blister packaging contained a bent needle; however, its plastic shield showed no damage or perforations.This condition could occur if a jam occurred during the plastic shield assembly process.A device history record review was completed for material number 305902, lot 5157464.The review confirmed that all visual inspections were performed according to requirements, with no quality notifications related to the reported condition.The lot was inspected and accepted based on the inspection control plan and subsequently approved for shipment.Additional device history records were reviewed for each batch of needles used in manufacturing this final lot, and no documentation indicated this type of defect during the entire production run.Verification of the shielder was also performed, confirming that settings were correct and product flow was consistent.To date, no other similar events have been reported for this lot.Based on the investigation and analysis of the returned sample, the customer¿s reported symptom of a bent needle has been confirmed.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23384000
• Report Number: 1213809-2025-00675
• Device Sequence Number: 21011957
• Product Code: FMI
• UDI-Device Identifier: 00382903059027
• UDI-Public: (01)00382903059027(11)250606(17)300531(10)5157464
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305902
• Device Lot Number: 5157464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown